PINE BROOK, N.J.(BUSINESS WIRE)
Alvogen subsidiary, Lotus Pharmaceuticals (Lotus), today announced
that Celgene filed a suit on 6 September 2017 in the United States
District Court for the District of New Jersey. The lawsuit was filed
under provisions of the Hatch-Waxman Act, resulting in a stay of final
Food and Drug Administration(FDA)approval of Lotus Abbreviated New
Drug Application (ANDA) for up to 30 months from the date the
plaintiffs, Celgene, received notice of Lotus' ANDA filing or until
final resolution of the matter before the court, whichever occurs
sooner, subject to any other exclusivities.
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Robert Wessman Chairman and CEO (Photo: Business Wire)
Lotus filed an ANDA with the United States FDA seeking regulatory
approval to market a generic version of Revlimid. Lotus ANDA
included a paragraph IV certification with respect to the patents listed
in the FDA's listing of Approved Drug Products with Therapeutic
Equivalence Evaluations (the Orange Book).
Lotus ANDA product is a generic version of Celgene's Revlimid 2.5, 5,
10, 15, 20 and 25 mg, which is indicated for the treatment of several
hematological malignancies including multiple myeloma. The product was
developed by Lotus pharmaceuticals in Taiwan.
Robert Wessman, Alvogen Chairman and CEO, said, The FDA
acceptance of our ANDA filing is an important milestone for our U.S.
business and great news for patients, who will finally have access to a
more affordable treatment. I would like to thank our teams in the U.S.
and Taiwan for their valuable efforts in submitting this filing.
Revlimid is a trademark of Celgene Corporation.
Alvogen currently has 75 products in development and pending FDA
approvals for the U.S. market. Annual brand sales for filed products and
those under development exceeds $25 billion, according to IMS Health
Alvogen is a global, privately owned pharmaceutical company focused on
developing, manufacturing and selling generic, brand, over-the-counter
brands (OTC) and biosimilar products for patients around the world. The
company has commercial operations in 35 countries with 2,800 employees
and operates four manufacturing and development hubs in the US, Romania,
Korea and Taiwan. North America is Alvogen's single largest market and
other key markets include: South Korea, Russia, Hungary, Romania,
Taiwan, Ukraine, Japan and China.
A consortium of investors, led by CVC Capital Partners and including
Singapore-based investment company Temasek and Vatera Healthcare
Partners, acquired a majority stake in Alvogen in June 2015.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170911005513/en/
Halldor Kristmannsson, (+354) 522-2900
Corporate Marketing & Media Relations